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Navigenics Says Consumer Genetics Market May Segment; ACMG Urges Home-Grown Standards

Companies in the nascent array-based consumer genetics testing market may begin to differentiate themselves in response to pressure from at least one state health agency, and should work together to develop standards that will ensure the success of the industry, according to industry experts.
Mari Baker, CEO of personal genetics company Navigenics, last week told BioArray News that as regulatory requirements in the US and individual states evolve to meet changes in genetic technologies, some companies may position themselves as providers of genetic tests that assess genetic predisposition for certain diseases, while others may focus more on recreational genetics, such as determining genetic ancestry.
“What we are hearing from people is that there is a notion that there may be some segmentation that occurs” in the market, Baker said last week. “I think what you see going on is that there are a lot of companies entering the market, and there will be segmentation in the market place. We are not quite there yet, but it is on its way to sorting through by questions around standards and regulatory issues.”
Navigenics, whose Health Compass service focuses solely on assessing genetic risk for certain health conditions, first began publicly discussing its service last November. Health Compass, launched this month, is a $2,500 service that uses Affymetrix SNP-genotyping arrays to assess an individual’s risk for 18 different conditions — including Alzheimer’s disease, multiple sclerosis, prostate cancer, and diabetes — and provides genetic counseling on how to mitigate those risks (see BAN 4/8/2008).
With Navigenics in this market are other array-based services such as 23andMe’s Personal Genome Service unit, DeCode Genetics’ DeCodeMe service, SeqWright, and GATC Biotech (see BAN 1/29/2008, see BAN 11/20/2007).
These services are typically priced at slightly under $1,000 and, unlike Navigenics’ service, offer information about ancestry and family inheritance.
According to Baker, it is possible that some of these companies could eventually position themselves as more recreational services, while services like Navigenics’ would be more devoted to determining users’ genetic predisposition to acquiring certain conditions.
Regulatory Issues
Questions about how personal genetics companies offer their services to the market have been raised by companies and third parties, particularly over the past month. On April 1, for example, 23andMe co-founders Linda Avey and Anne Wojcicki apologized to users on the company’s blog, the Spittoon, for delays related to moving their service to a CLIA-approved lab.
“Because 23andMe is creating an entirely new kind of business in delivering personal genetic information, the regulatory requirements we face are both complicated and uncertain,” Avey and Wojcicki wrote. “Because of the way these requirements are evolving, we recently changed the laboratory where our customers’ saliva samples are processed.”
23andMe began its service by using Illumina whole-genome genotyping array technology. It is not clear whether Illumina is still processing its samples. A spokesperson this week declined to answer questions about where 23andMe is running its samples.

“Consumer safeguards are important to have in place for the industry to succeed.”

The issues surrounding personal genetic testing grew last week when  reported that the New York State Department of Health had sent 23 warning letters to companies involved in the market, including Navigenics, 23andMe, Affymetrix, and Illumina, and urged them to obtain state permits before offering what it considers medical genetic tests.
New York residents are also required to obtain a physician’s recommendation to use personal genetics services, the state argued.
Baker said that one of the reasons Navigenics opted to use a CLIA-approved lab was because it was aware that its service would sooner or later come under regulatory scrutiny. She said that Affymetrix has submitted an application to New York State health authorities to receive a permit to provide medical testing.
“Affy already has a CLIA license, but New York State has separate regulatory statutes,” she said. Affy’s application is still being processed and Navigenics has opted to put New York customers on a waiting list until it gets the go-ahead from the state. Despite this, Baker said that Navigenics should not have trouble meeting the other requirements to resume offering Health Compass to New Yorkers.
“We have genetic counseling in place and we have a New York physician in place,” she said. “We have put in place the services required as far as New York State regulations require.”
An Affy company spokesperson this week said that the company is “committed to working with New York authorities to obtain certification for its CLIA laboratory” and that it will “continue to provide authorities in New York with the information they require to grant certification.”
The spokesperson for 23andMe said that the company has responded to concerns of the state of New York and continues to engage in a” productive dialogue” with them.  “23andMe continues to work with regulators to develop appropriate regulations, and is happy with the progress being made," she said.
Baker said that Navigenics probably will not face similar hurdles in other states because of its CLIA certification, and its association with a network of licensed physicians who can interpret the Health Compass results, and genetic counselors.
“We are trying to approach this in a way that is consistent with the regulatory environment that exists,” she said.
Standard Bearers
Another event that is impacting the public debate about direct-to-consumer genetic testing emerged last week when the American College of Medical Genetics issued an advisory statement to the public and the health-care community stating that consumers need to be counseled on the utility and meaning of direct-to-consumer genetic tests.
The group advised counselors and doctors to become more closely involved with consumers when making choices about these tests, and called for greater oversight and regulation.
The group issued five recommendations for health-care providers, businesses, regulators, and consumers to consider. First, companies offering such tests should have “a knowledgeable professional” involved in ordering and interpreting a genetic test.” The group stressed that consumers should be well-informed of the test and argued that the “scientific evidence on which a test is based should be clearly stated,” ACMG said.
Next, labs that offer these services “must be accredited by CLIA, the State, and/or other applicable accrediting agencies.” Finally, the group urged companies in the market to protect the privacy of their users.
For its part, Navigenics this month also created 10 standards it believes should be implemented across the industry. Currently, the proposed standards include such criteria as validity, accuracy, and clinical relevance, and address security and privacy issues, emphasizing an individual’s right to control who has access to their genetic information and the need to follow HIPAA regulations (see BAN 4/8/2008).
Navigenics also said that it will present and solicit information about the standards at a meeting later this year organized in conjunction with the Personalized Medicine Coalition. Last week, Baker said that the shop is open to working with other companies in the consumer genetics market to develop and enforce standards.
“We are providing open invitations and we have to see who will accept and participate and how that will unfold,” she said. “Our belief is that we are at the forefront of establishing not just a company, but an industry. It is important that everybody delivering this information abides by a set of quality standards. Consumer safeguards are important to have in place for the industry to succeed.”
However, Baker sought to distinguish Navigenics from its rivals, even though its competitors also assess their clients’ risk for developing certain diseases. “We are the only people who are focused solely on this broad base of actionable health conditions and solely on the actionable health conditions,” said Baker. “There are other players where you can get a broad range [of information], from ancestry to health predisposition, but we are the only people that are focused solely on how this information is applied from health perspective.”

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